Deployment Model:
Cloud (SaaS)
Target Company Size:
Enterprise
Modules Included:
CAPA, Change Control, Complaint Handling, Risk Management, Audit Management, Design Control, Other
Compliance Standards:
ISO 13485:2016, FDA QMSR (21 CFR Part 820), EU MDR/IVDR, 21 CFR Part 11, ISO 14971, Other
Part11 Support:
Yes
Implementation Timeline:
Custom
Integration Options:
Microsoft technology (Business Analytics and AI powered workflows)
Regions Served:
Global